跳至主要内容
临床试验/NCT00192725
NCT00192725已完成不适用

Tryptophan Depletion in Acute Mania - A Randomized Controlled Trial

Rambam Health Care Campus2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2003年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Reduction in Young Mania Rating Scale score

研究概览

简要总结

Serotonin (5-HT) is important in mood regulation and is believed to play a major role in the pathophysiology of major depression (MD). Selective serotonin reuptake inhibitors (SSRIs) are currently the most widely used drugs for the treatment of depression. Patients with bipolar disorder (BD) who are treated for depression with SSRIs might develop mania, which is believed to be triggered by antidepressant treatment. Rapid tryptophan depletion (RTD) has been shown to induce transient depressive symptoms in remitted depressed patients treated with SSRIs. In remitted manic patients treated with lithium, RTD does not seem to have clinical effects. However, RTD was not studied in acutely manic patients and could theoretically have antimanic properties. In this double blind randomized placebo controlled study RTD will be used as a tool to assess the role of 5-HT in mania and will be evaluated for its antimanic properties and potential use as augmentation to drug treatment in acute mania.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute mania
  • Ability to provide written informed consent

排除标准

  • Mixed affective states
  • Suicidal ideation
  • Uncontrolled systemic illness

结局指标

主要结局

Reduction in Young Mania Rating Scale score

时间窗: Before and after intervention

次要结局

  • Clinical Global Impression(Before and after intervention)

研究者

申办方类型
Other

研究点 (2)

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